BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM*STM ST,36+8L NK,20X15X165

    MDR report key: 2232222 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15918
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    October 28, 2010
    Report Date
    July 19, 2011
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JDI
    PMA / PMN Number
    K851422
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(4) 2012 - IMPLANT STICKER SHEET (PROVIDING PART AND LOT NUMBERS) AND REVISION OPERATIVE REPORT RECEIVED. IN ADDITION TO THE FRACTURED STEM, OPERATIVE REPORT STATES THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE WITH GROSS MOVEMENT NOTED BETWEEN THE PROXIMAL CONE AND REMAINING PROXIMAL FEMORAL BONE STOCK. SLEEVE ADDED TO COMPLAINT. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    LITIGATION PAPERS ALLEGE: THE S-ROM STEM WAS IMPLANTED IN PATIENT ON (B)(6) 2004, DURING A REVISION OF A TOTAL RIGHT HIP ARTHROPLASTY. PATIENT BEGAN TO EXPERIENCE RIGHT HIP PAIN IN (B)(6) 2010. ON (B)(6) 2010, REVISION CONFIRMED THAT THE STEM HAD FRACTURED. DOI: (B)(6) 2004 - DOR: (B)(6) 2010 (RIGHT SIDE). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: THE S-ROM STEM WAS IMPLANTED IN PATIENT ON (B)(6), 2004, DURING A REVISION OF A TOTAL RIGHT HIP ARTHROPLASTY. PATIENT BEGAN TO EXPERIENCE RIGHT HIP PAIN IN (B)(6) 2010. AN (B)(6), 2010 REVISION CONFIRMED THAT THE STEM HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM*STM ST,36+8L NK,20X15X165 STEM - HIP IMPLANT JDI DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 1238063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention